Somatoform DisordersNCT01590992
Treatment of Globus Sensations With Psychotherapy
A study testing Exposure-based psychotherapy for somatic symptoms and Relaxation therapy in people with Somatoform Disorders and Globus Hystericus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether psychotherapy (based on exposure techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform Disorders (as exemplified here in subjects with globus sensations in the throat). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Somatoform Disorders, Globus Hystericus
- What is being tested?
- Exposure-based psychotherapy for somatic symptoms and Relaxation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sufficient spoken and written knowledge of German
- Presence of globus sensations and somatoform disorder
- Clinically significant impairment
Who cannot join
- Current (past 12 months) severe chronic physical illnesses, especially neurological, endocrine or metabolic diseases
- Current (past 12 months) substance dependence or eating disorder
- Lifetime history of psychotic disorder or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychotherapy and Psychobiology of Somatoform Disorders (Globus Sensations): A Randomized Controlled Trial
The purpose of this study is to determine whether psychotherapy (based on exposure techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform Disorders (as exemplified here in subjects with globus sensations in the throat).
Read the detailed description
Functional somatic symptoms (FSS) and somatoform disorders are characterized by the presence of medically unexplained symptoms. They are among the most prevalent disorders in the general medical setting, leading to individual suffering and having huge impact on public health alike. Unfortunately, many patients still remain untreated and not all patients get better, even when receiving currently proposed treatments. The aim of the present project is twofold: First, we want to improve the understanding of risk factors and psychobiological processes leading to the development of FSS. Second, we will explore and evaluate new ways of treating subjects with FSS. Within the project, we will examine subjects with globus sensations in the throat, a very common und impairing form of FSS. The proposed study i) may provide insight into the development of FSS, thereby improving our way by which we recognize and diagnose subjects with FSS, and ii) may help fostering our understanding of how to better treat subjects suffering from FSS.
- Conditions
- Somatoform Disorders, Globus Hystericus
- Being tested
- Exposure-based psychotherapy for somatic symptoms, Relaxation therapy
- Keywords
- Somatoform disorder, Functional Somatic Syndrome, Functional Somatic Symptoms, Somatic Symptom Disorder, globus sensation, globus pharynges, globus hystericus
- Medical subject headings
- Somatoform Disorders, Globus Sensation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure-based psychotherapy for somatic symptomsBehavioural
Also called Behavioral therapy for somatic symptoms, Behavioural therapy for somatic symptoms, Exposure-therapy for somatic symptoms, Exposure-based psychotherapy for somatoform disorders
Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes)
Relaxation therapyBehavioural
Also called Progressive relaxation
Progressive muscle relaxation (Jacobson)
| Study group | Role | What they receive |
|---|---|---|
| Exposure-based Psychotherapy for Somatic Symptoms | Experimental | First: 1-2 months waiting period; followed by: exposure-based psychotherapy Receives: Behavioral: Exposure-based psychotherapy for somatic symptoms |
| Relaxation Therapy | Active comparator | First: 1-2 months waiting period; followed by: relaxation therapy Receives: Behavioral: Relaxation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale - indirect (change from baseline)
German version
Measured: Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline)
Glasgow-Edinburgh Throat Scale (change from baseline)
German version
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Functional Esophageal Disorder Module Interview (change from baseline)
German version
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Screening for somatoform disorder (SOMS-7) (change from baseline)
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Secondary outcomes (11)
Acceptance & Action Questionnaire (AAQ-II)
German version
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Fragebogen zu Körper und Gesundheit (FKG-SSAS)
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Daily Symptom Exposure Interview
German version
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Hospital Anxiety and Depression Scale
German version
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Positive and Negative Affect Scale
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Sheehan Disability Scale
German version
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Whiteley Index
German version
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Salivary Cortisol Awakening Response
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
DNA-methylation
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Questions on adverse/side effects
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
psychophysiological reaction after symptom-relevant stimulus exposure
Measured: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Somatoform DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Basel, Swiss National Science Foundation
- Responsible party
- Sponsor
- Investigators
- Gunther Meinlschmidt, Ph.D., Study director, University of Basel, Ruhr-University BochumRoselind Lieb, Ph.D., Study director, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590992
- Sponsor's protocol ID
- PT1_135328_A
- Status last verified
- Oct 2018
- First submitted
- 11 Apr 2012
- Last updated
- 24 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Imperiale MN, Lieb R, Meinlschmidt G. Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study. Sci Rep. 2023 Sep 20;13(1):15615. doi: 10.1038/s41598-023-42186-y.
PubMed 37730963
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychotherapy and Psychobiology of Somatoform Disorders (Globus Sensations): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01590992
- Acronym / sponsor ID
- PT1_135328_A
- Conditions
- Somatoform Disorders, Globus Hystericus
- Keywords
- Somatoform disorder, Functional Somatic Syndrome, Functional Somatic Symptoms, Somatic Symptom Disorder, globus sensation, globus pharynges, globus hystericus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- University of Basel, Swiss National Science Foundation
- Study start
- May 2012
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether psychotherapy (based on exposure techniques) is effective in the treatment of functional somatic symptoms (FSS)/Somatoform Disorders (as exemplified here in subjects with globus sensations in the throat).
Detailed description
Functional somatic symptoms (FSS) and somatoform disorders are characterized by the presence of medically unexplained symptoms. They are among the most prevalent disorders in the general medical setting, leading to individual suffering and having huge impact on public health alike. Unfortunately, many patients still remain untreated and not all patients get better, even when receiving currently proposed treatments. The aim of the present project is twofold: First, we want to improve the understanding of risk factors and psychobiological processes leading to the development of FSS. Second, we will explore and evaluate new ways of treating subjects with FSS. Within the project, we will examine subjects with globus sensations in the throat, a very common und impairing form of FSS. The proposed study i) may provide insight into the development of FSS, thereby improving our way by which we recognize and diagnose subjects with FSS, and ii) may help fostering our understanding of how to better treat subjects suffering from FSS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure-based Psychotherapy for Somatic Symptoms | Experimental | Behavioral: Exposure-based psychotherapy for somatic symptomsFirst: 1-2 months waiting period; followed by: exposure-based psychotherapy |
| Relaxation Therapy | Active comparator | Behavioral: Relaxation therapyFirst: 1-2 months waiting period; followed by: relaxation therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sufficient spoken and written knowledge of German
- Presence of globus sensations and somatoform disorder
- Clinically significant impairment
Key exclusion criteria (3 listed)
- Current (past 12 months) severe chronic physical illnesses, especially neurological, endocrine or metabolic diseases
- Current (past 12 months) substance dependence or eating disorder
- Lifetime history of psychotic disorder or bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure-based psychotherapy for somatic symptomsAlso: Behavioral therapy for somatic symptoms, Behavioural therapy for somatic symptoms, Exposure-therapy for somatic symptoms, Exposure-based psychotherapy for somatoform disordersApplication of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes) | Behavioural | Exposure-based Psychotherapy for Somatic Symptoms |
| Relaxation therapyAlso: Progressive relaxationProgressive muscle relaxation (Jacobson) | Behavioural | Relaxation Therapy |
Primary outcome
Clinical Global Impression Scale - indirect (change from baseline)
Time frame: Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline)
German version
Glasgow-Edinburgh Throat Scale (change from baseline)
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
German version
Functional Esophageal Disorder Module Interview (change from baseline)
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
German version
Screening for somatoform disorder (SOMS-7) (change from baseline)
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
11 secondary outcomes
Acceptance & Action Questionnaire (AAQ-II)
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Fragebogen zu Körper und Gesundheit (FKG-SSAS)
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Daily Symptom Exposure Interview
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Hospital Anxiety and Depression Scale
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Positive and Negative Affect Scale
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Sheehan Disability Scale
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Whiteley Index
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
Salivary Cortisol Awakening Response
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
DNA-methylation
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Questions on adverse/side effects
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline), Follow-up 1 (exp. average of 6 months after post-therapy), Follow-up 2 (exp. average of 24 months after post-therapy)
psychophysiological reaction after symptom-relevant stimulus exposure
Time frame: Baseline, after waiting period (exp. average of 8 weeks after baseline), post-therapy (exp. average of 16 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2018.
- Derived from this study: PubMed 37730963Imperiale MN, Lieb R, Meinlschmidt G. Treatment-associated network dynamics in patients with globus sensations: a proof-of-concept study. Sci Rep. 2023 Sep 20;13(1):15615. doi: 10.1038/s41598-023-42186-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunther Meinlschmidt, Ph.D. study director
University of Basel, Ruhr-University Bochum
Roselind Lieb, Ph.D. study director
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure-based psychotherapy for somatic symptoms and Relaxation therapy in people with Somatoform Disorders and Globus Hystericus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression Scale - indirect (change from baseline) (time frame: Baseline, after waiting period (an expected average of 8 weeks after baseline), post-therapy (expected average of 16 weeks after baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590992, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2018.